MHRA advice on responding to GLP and GCP inspection reports

The Medicines and Healthcare products Regulatory Authority (MHRA) has released guidance for industry on preparing responses to good laboratory practice (GLP) and good clinical practice (GCP) inspection reports.

The guide provides a format that, whilst not mandatory, is the inspectorate’s preferred method for providing responses. Adhering to the format should increase the speed with which a compliance decision is reached after the inspection. The core format is outlined below:

Initial Site response

  • Choose a new colour for the first set of responses
  • Answer the deficiencies raised directly underneath, ideally using the Word version of the inspection report provided
  • Reponses should be clear and concise, any responses with irrelevant information may be returned without review and with a request to rewrite and simplify
  • If the company do not believe a deficiency should be raised, they should contact the lead inspector
  • It should be clearly stated, what any actions will be and when they will be completed by (DDMMYYYY).
  • A root cause should be determined as part of the response and consideration should be taken of the wider systemic impact of this on other sites in the organisation and the studies conducted
  • If a review of similar areas to find similar deficiencies has been conducted but has flagged up nothing, this should be stated with a description of how the review was conducted.
  • Choose appropriate timelines that are realistic
  • Where a complex solution requires a long timeline to be implement but operations are continued, supporting rationale must be provided and interim actions designed to control the deficiency must be implemented
  • There is no need to provide evidence unless specifically required
  • Responses must be provided in an editable Word document to allow the inspector to respond (where necessary)
  • Hard copies are not required and won’t be reviewed.

MHRA requests for further information

  • Where the inspector requires further information, the request will be in red font directly below the point that they require further information for and each request will be dated.

Site second response

  • A new colour should be chosen for all sets of responses, and replies should be included underneath the request for further information
  • Each new response should be dated
  • Previous response text must not be changed when providing additional information or further responses.

This format applies to ‘major’ and ‘other’ deficiencies. Since critical deficiencies are more complex in nature, responses may take different formats depending on the issues cited.

When it comes to completing corrective and preventive actions (CAPA) in response to the inspection, the organisation must communicate with inspectors if it is expected that a timeline commitment will not be met, in advance of this happening. This is crucial as delays in completing such actions can cause significant compliance issues for facilities and studies. Furthermore, CAPA implementation will be reviewed at the next inspection and failure to adequately address or complete within the agreed timelines may lead to critical findings being given by the inspector.

To inform the MHRA of any significant changes at a test facility, email gxplabs@mhra.gov.uk. For GLP facilities, a notification of change form must be completed to inform the Good Laboratory Practice Monitoring Authority of the details of the change.

To view the guidance in full, click here.